This study is to elucidate the impact of germline mutations and clonal hematopoiesis (CHIP) on the progression of early aortic valve calcification in patients with bicuspid aortic valves. The study will be conducted over a recruitment period of one year and a follow-up observation period of two years. Considering a 2-year event rate and a 33% occurrence rate of clonal hematopoiesis, each group requires a minimum of 102 participants. Accounting for a 15% dropout rate, a total of 120 participants are needed for each group (type I error (α) = 5%, type II error (β) = 20%). Therefore, the total study population, including patients with normal aortic valve function, is set at 240 participants.
Study Type
OBSERVATIONAL
Enrollment
240
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGPresence of germline mutation
Time frame: 2 years follow-up
Clonal hematopoiesis of indeterminate potential (CHIP) mutation
Clonal hematopoiesis of indeterminate potential (CHIP) is the presence of a clonally expanded hematopoietic stem cell caused by a leukemogenic mutation.
Time frame: 2 years follow-up
Progression of aortic valve calcification
Progression of aortic valve calcification measured by computed tomography (AV calcium score) or Echocardiography (Progression of AS/AR)
Time frame: 2 years follow-up
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